The following data is part of a premarket notification filed by Isle Media And Sterile Products, Inc. with the FDA for Modified Thayer-martin Medium.
Device ID | K791470 |
510k Number | K791470 |
Device Name: | MODIFIED THAYER-MARTIN MEDIUM |
Classification | Culture Media, For Isolation Of Pathogenic Neisseria |
Applicant | ISLE MEDIA AND STERILE PRODUCTS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | JTY |
CFR Regulation Number | 866.2410 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-07-24 |
Decision Date | 1979-08-22 |